Hartland,

I do not have enough knowledge of or experience with FDA (and other regulatory agencies) and the clinical trial design end of things to have an opinion on this. It sure would be nice to have US included in the BETonMACE trial. But does the inclusion or exclusion of US from the trial impact the quality of the trial? I don't know. Don said Europe and Asia in his webcast. So did the meeting with the European EMA go well? As has been said before, a concrete statement from Don regarding the outcome of the recent FDA and EMA talks is long overdue, since these discussions were supposed to have happened in April and May. As for Asia, is it just China and the territories described in the Hepalink deal, or other Asian countries as well. Our next chance to hear something is likely June 30th special meeting.